Updates to the Recommendations for the Use of Antiretroviral Drugs During Pregnancy and Interventions to Reduce Perinatal HIV Transmission in the United States
The Panel on Treatment of HIV in Pregnancy and Prevention of Perinatal Transmission (the Panel) updated the Recommendations for the Use of Antiretroviral Drugs During Pregnancy and Interventions to Reduce Perinatal HIV Transmission in the United States.
The clinical guidelines for infant feeding now support shared decision making and clarify breastfeeding options for people with HIV on antiretroviral therapy with sustained undetectable viral load (levels of virus in the blood). Additional updates include revised and reorganized content and some revised section titles. Highlights from the updated sections are summarized below:
Pre-Exposure Prophylaxis (PrEP) to Prevent HIV During Periconception, Antepartum, and Postpartum Periods
- This section was updated in accordance with the current Centers for Disease Control and Prevention guidelines for HIV PrEP.
Antepartum Care for Individuals With HIV
- This section, formerly titled General Principles Regarding Use of Antiretroviral Drugs During Pregnancy, was revised to focus on pregnancy-related care and Table 4. Antepartum Screenings and Assessments for Pregnant People With HIV was added.
Recommendations for the Use of Antiretroviral Drugs During Pregnancy: Overview
- The Panel has reorganized and revised content to provide a comprehensive overview on the individualized selection of antiretroviral (ARV) drugs and recommendations for the use of ARV drugs during pregnancy, with links to updated scenario-specific content in other sections and Appendix C: Antiretroviral Counseling Guide for Health Care Providers.
- The Panel points out that pregnancy, lactation, and the potential for pregnancy should not preclude the use of drug regimens that would be chosen for people who are not pregnant, unless adequate drug levels are not likely to be attained in pregnancy or there are known adverse effects that outweigh potential benefits (AIII).
Use of Antiretroviral Drugs to Prevent Perinatal HIV Transmission and Improve Maternal Health
- This new section outlines core components and associated data about the use of ARV drugs before and during pregnancy to improve maternal health and prevent perinatal HIV transmission, including ARVs for newborns with perinatal HIV exposure.
People With HIV Who Are Trying to Conceive
- This new section was added to provide a short overview about recommendations regarding ART for people who are trying to conceive.
- The Panel recommends that the use of contraception, regardless of type, should not be required to initiate or continue ARVs that would otherwise be recommended for an individual patient, even if there are limited data in pregnancy (AIII).
People With HIV Who Are Taking Antiretroviral Therapy When They Become Pregnant
- The Panel recommends that pregnant people who present to care on long-acting injectable CAB and RPV during pregnancy should be counseled about limited data. The Panel now recommends that clinicians and pregnant people reach a shared decision about continuing this regimen with frequent viral load monitoring or switching to one of the Preferred or Alternative three-drug ARV regimens (CIII).
Table 6. What to Start: Initial Antiretroviral Regimens During Pregnancy for People Who Are Antiretroviral-Naive
- The table was revised to reflect updated Panel recommendations and to list the advantages and disadvantages of ARV combinations and regimens.
Table 7. Situation-Specific Recommendations for Use of Antiretroviral Drugs in Pregnant People and Nonpregnant People Who Are Trying to Conceive
- The Panel now recommends raltegravir (RAL) and ritonavir-boosted atazanavir (ATV/r) as Alternative rather than Preferred ARVs for use in pregnancy and for people who are trying to conceive.
- Although there are insufficient data about the use of BIC and DOR in pregnancy, the Panel recommends that pregnant people who present on these regimens with a suppressed viral load may continue their current treatment with frequent viral load monitoring or consider switching to an ARV regimen that is recommended for use in pregnancy.
- The Panel recommends that pregnant people with HIV should not delay initiating ART due to concerns about teratogenicity with first-trimester exposure (AIII).
- Table 8. Drug-Specific Risk Assessment by the Antiretroviral Pregnancy Registry was added to provide an overview of risk assessment across drugs.
Early (Acute and Recent) HIV Infection
- For pregnant people with early HIV infection who have previously used long-acting CAB as PrEP, the Panel recommends initiating ART with a ritonavir-boosted, darunavir-based regimen pending the results of genotype testing for integrase strand transfer inhibitor–resistance mutations (AII).
- The former section, Counseling and Managing Individuals With HIV in the United States Who Desire to Breastfeed, was revised and retitled to provide more comprehensive guidance on feeding infants born to individuals with HIV.
- The Panel recommends that people with HIV receive evidence-based, patient-centered counseling to support shared decision-making about infant feeding. Counseling about infant feeding should begin prior to conception or as early as possible in pregnancy; information about and plans for infant feeding should be reviewed throughout pregnancy and again after delivery (AIII).
- Replacement feeding with formula or banked pasteurized donor human milk is recommended to eliminate the risk of HIV transmission through breastfeeding when people with HIV are not on ART and/or do not have a suppressed viral load during pregnancy (at a minimum throughout the third trimester), as well as at delivery (AI).
- Individuals with HIV who are on ART with a sustained undetectable viral load and who choose to breastfeed should be supported in this decision (AIII).
Antiretroviral Management of Newborns With Perinatal HIV Exposure or HIV Infection
- When the criteria for low risk of perinatal HIV transmission are met, the Panel now recommends that infants with perinatal HIV exposure receive 2 weeks of zidovudine (ZDV) prophylaxis (BII), rather than 4 weeks.
- Infants born to individuals who do not meet the criteria for low risk of perinatal HIV transmission but who have a viral load <50 copies/mL at or after 36 weeks should receive ZDV for 4 to 6 weeks (BII).
- All premature infants <37 weeks gestation who are not at high risk of perinatal acquisition of HIV should receive ZDV for 4 to 6 weeks (BII).
- New subsections and Table 12. Infant Antiretroviral Prophylaxis for Newborns of Mothers with Sustained Viral Suppression Who Breastfeed were added to address ARV prophylaxis for newborns at low risk of perinatal HIV transmission who are breastfed and to provide information about breastfeeding in newborns at high risk of perinatal HIV acquisition.
Diagnosis of HIV Infection in Infants and Children
- This section now provides additional guidance on HIV diagnostic testing for infants with perinatal HIV exposure who are being breastfed in the text and in Table 13. Recommended Virologic Testing Schedules for Infants Who Were Exposed to HIV According to Risk of Perinatal HIV Acquisition at and After Birth.
Appendix B: Safety and Toxicity of Individual Antiretroviral Agents in Pregnancy
Table 14. Antiretroviral Drug Use in Pregnant People With HIV: Pharmacokinetic and Toxicity Data in Human Pregnancy and Recommendations for Use in Pregnancy was updated, and individual drug sections were updated with new data and revised to include summary bullet points about pharmacokinetics and dosing, teratogenicity, and safety or other issues.
For a list of recent updates, please see What's New in the Guidelines. To view or download the guidelines, go to the Perinatal HIV Clinical Guidelines section of Clinicalinfo’s website. The guidelines tables and recommendations also can be downloaded as separate PDF files.
Note: The term “breastfeeding” is used to describe feeding a child one’s own milk (either direct feeding or with expressed milk). When counseling individuals with HIV about infant feeding, it is important to assess and use their preferred terminology; some transgender men and gender-diverse individuals may prefer using the term “chestfeeding” rather than “breastfeeding.” We urge providers to consult community-based resources for more information about inclusive, affirming language around gender in health care settings.
Clinicalinfo welcomes your feedback on the latest revisions to the Recommendations for the Use of Antiretroviral Drugs During Pregnancy and Interventions to Reduce Perinatal HIV Transmission in the United States. Please send your comments with the subject line “Perinatal HIV Clinical Guidelines” to HIVinfo@NIH.gov by February 21, 2023.